THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

Swiss Ethics Committee Defends Precautionary Principle in Regulating New Biotechnologies

The rapid development of new biotechnologies such as CRISPR-Cas systems and other genome editing processes has evoked debate worldwide. In Switzerland, the Gene Technology Act of 2003 imposes strict authorisation procedures for the use of gene technologies in non-human biotechnology. Some believe that the new biotechnologies should be exempt from these authorisation requirements. Others such as the relevant Swiss authorities, invoke the precautionary principle and insist that treating the new technologies and genetic engineering procedures in the same way under the law is (currently) justifiable, since the use of these new technologies in the environment involves considerable uncertainty and lack of knowledge, linked with the fear that, in complex systems such as those found in the environment, possible slight modifications could lead to widespread damage.

The precautionary principle (or precautionary approach) is a concept originally found in environmental law. If serious damage is not merely conceivable, but there is also a scientifically plausible foundation for the fear that such damage could occur, then a precautionary obligation exists.

The Swiss Federal Ethics Committee on Non-Human Biotechnology (ECNH) is an advisory committee that advises the Government on matters of regulation and enforcement of legislation in the field of non-human biotechnology. It has produced a report examining the ethical significance of precaution and the ethical justification of precautionary obligations. Among its recommendations are:

1.      Adhering to the concept of precaution in the regulation of new biotechnologies, to establish it firmly in the further development of environmental law and to support its application at international level.

2.      Strengthening the framework conditions of the scientific institutions in such a way that they are able to meet the criteria for risk analysis in a scientifically independent manner and can consistently demand that all actors comply with the scientific standards and justification requirements. Moreover, they must be able to present these decisions concerning risk to the public affected by them.

3.      Respecting the different roles of expert committees and of decision-making authorities and the courts. Decision-making within specialised bodies advising the competent authorities must be subject to democratic control and transparency.

4.  Decisions on how to deal with technologies are based on risk assessments that involve making decisions about values. In democratic societies, the responsibility for these value decisions lies with the citizens, not with scientists. Awareness of this fact must also be raised among the employees of authorities who implement such value decisions when assessing individual cases.

We reproduce below the Conclusions and Recommendations of the report. The full report is available at:http://www.ekah.admin.ch/fileadmin/ekah-dateien/dokumentation/veranstaltungen/Veranstaltung_7._Mai_2018/EKAH_Broschu__re_Vorsorge_Umweltbereich_e__18_Web_V2.pdf

With best wishes,

PRECAUTION IN THE ENVIRONMENTAL FIELD

Report of the Federal Ethics Committee on Non-Human Biotechnology (ECNH)

May 2018
http://www.ekah.admin.ch/fileadmin/ekah-dateien/dokumentation/veranstaltungen/Veranstaltung_7._Mai_2018/EKAH_Broschu__re_Vorsorge_Umweltbereich_e__18_Web_V2.pdf

Conclusions

The rapid development of new biotechnologies such as CRISPR-Cas systems and other genome editing processes opens up new opportunities and promises a wide range of applications, although it is yet to be seen whether all this potential can be realised. At the

same time, the new technologies and their application potential confront us with considerable uncertainties. On the one hand, we do not know everything about how the new technologies function or about their impact on organisms on which they are applied. If the technologies and organisms which have been altered by the processes come into contact with the environment, this not only increases the complexity of possible interactions, but also our uncertainties.

Environmental law responds to this epistemic situation of uncertainty with the legal concept of the precautionary principle or precautionary approach. If serious damage is not merely conceivable, but there is also a scientifically plausible foundation for the fear that such damage could occur, then a precautionary obligation exists. In its report, the ECNH concludes that the concept of precaution in environmental law and the precautionary measures to which it gives rise can also be justified ethically, irrespectively even of the underlying risk ethics theory.

Recommendations

1.      Consistent strengthening and application of the idea of precaution. With regard to new biotechnologies, the applicability of the legal concept of precaution is frequently questioned. The ECNH concludes in its report that the idea of precaution can also be legitimised ethically, irrespective of the underlying theories of risk ethics. This leads to the ECNH’s first recommendation, namely to adhere to the concept of precaution in the regulation of new biotechnologies, to establish it firmly in the further development of environmental law and to support its application at international level.

The question of how to deal with epistemic uncertainties and thus with precaution situations is closely related to the question of how we generate knowledge. It also affects the political culture in which we make decisions dealing with technologies and uncertainty. The following recommendations therefore affect the conditions under which knowledge is acquired, as well as those under which political decisions are made.

2.      Improving the reliability of risk assessments. The data on which a risk analysis is based must satisfy scientific criteria. It is the responsibility of the scientific institutions to comply with these criteria, and they have their own mechanisms for doing so. The ECNH recommends strengthening the framework conditions of the scientific institutions in such a way that they are able to meet the criteria in a scientifically independent manner and can consistently demand that all actors comply with the scientific standards and justification requirements. Scientific data and assessments must also be verifiable and comprehensible in order to meet internal scientific controls and thus satisfy scientific criteria. This involves granting access to all information necessary for scientific evaluation, including to divergent data that does not support a scientific thesis.²⁰ Furthermore, attention must be paid to promoting and cultivating diversity of perspectives and cross-sectional competences.

Access to data and transparency of scientific assessments are also essential for the experts responsible in the decision-making authorities; they must be able to understand the plausibility of the scientific data and how they have been assessed, in order to be able to make reasoned decisions. Moreover, they must be able to present these decisions concerning risk to the public, which is affected by them, in a transparent and understandable manner. This is the only way to ensure that voters can form free and informed opinions, and thus that risk decisions also made reliably in the political process.

3.      Respecting the different roles of expert committees on the one hand and of decision-making authorities and the courts on the other. Decisions about dealing with new (bio)technologies in the environment have far-reaching consequences which are of relevance to the whole of society. The decisions may therefore not be left to individuals. It follows, therefore, that the democratically legitimate instances charged with making these decisions may not delegate them to others.

This also means that decision-making within specialised bodies advising the competent authorities must be subject to democratic control. Their decision-making process must be transparent and comprehensible, and majority opinions and minority positions must be presented openly and comprehensibly with justifications. Furthermore, given both the plurality of scientific opinions and the fact that the state may not delegate decisions in such matters, it follows that neither the decision-making authorities nor jurisdiction automatically accept the expert opinions of specialised advisory bodies. The decision-making authorities must therefore also have appropriately trained staff. They must be able to critically follow the plausibility checks and assessments made by the scientific institutions.

4.      Strengthening political awareness in dealing with technologies and uncertainties. Decisions   on how to deal with technologies involve uncertainties and possibly have far-reaching consequences. The decisions are based on risk  assessments that involve making decisions about values. In democratic societies, the responsibility for these value decisions lies with the citizens, not with scientists. Awareness of this fact must also be raised among the employees of authorities who implement such value decisions when assessing individual cases. If they are involved in this decision-making process as specialists, they do so on behalf of the political authority. Their role as scientists in this context is thus different from that of their colleagues in scientific institutions.

Ref:

20  In view of recent developments in science and education policy, care must be taken to ensure that conflicts of interest do not restrict impartial research at universities. Such restrictions not only compromise the independence of scientists but also alter the self-conception of scientific institutions. They may affect the quality of scientific data, influence the choice of research approaches and, at worst, lead to interest-based solutions and results. In all cases, such restrictions undermine confidence in the independence of science and the scientific quality of data and data assessment.